GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of GASTROINTESTINAL VIDEOSCOPE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus gastrointestinal videoscope has 120 adverse event reports, with no injuries and no deaths. Many describe image problems, such as no image or a poor or intermittent picture, and residue left after cleaning. Reports rose from 0 in the prior 12 months to 120 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 04953170423628), received between Dec 2, 2025 and Sep 30, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (36 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem36
- Failure to Clean Adequately17
- Poor Quality Image9
- Residue After Decontamination9
- No Display/Image8
- Erratic or Intermittent Display3
- Corroded2
- Device Reprocessing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions79
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Corroded; Communication or Transmission Problem
The customer reported an E315 scope detection error message during inspection for an unspecified procedure involving an Olympus gastrointestinal videoscope. Additionally, during the initial evaluation of the returned device a corroded charged coupled device unit was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950802 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941474 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
The customer reported that the gastrointestinal videoscope had a separate issue. During the initial evaluation of the device, white residue was observed in the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933083 ↗MalfunctionSep 28, 2026Misfocusing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925229 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported a communication error (E227) during an upper gastrointestinal procedure involving an Olympus gastrointestinal videoscope. The procedure was completed with the same device. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903019 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902489 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
The customer returned the Gastrointestinal videoscope for a separate issue. During the initial evaluation of the returned device, Incompatible scope (E315) was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889576 ↗MalfunctionSep 24, 2026No Display/Image; Communication or Transmission Problem
During inspection of the Gastrointestinal Videoscope, a scope communication error code (E227), no image display, and a black image were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884272 ↗MalfunctionSep 23, 2026Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876429 ↗MalfunctionSep 23, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873797 ↗MalfunctionSep 23, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873453 ↗MalfunctionSep 23, 2026Failure to Clean Adequately
The customer reported the gastrointestinal videoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed in the air/water supply cylinder and channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871718 ↗MalfunctionSep 22, 2026Poor Quality Image; Residue After Decontamination
The customer returned the gastrointestinal videoscope for a separate issue. During the initial evaluation of the returned device it was observed white residue inside the air/water channel, white residue inside the air/water cylinder and noisy in the image. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857322 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer reported that the Gastrointestinal Videoscope for a separate issue. During the initial evaluation of the device, white residue was observed in the air/water channel and the air/water cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851723 ↗MalfunctionSep 21, 2026Contamination; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849066 ↗MalfunctionSep 3, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50597361 ↗MalfunctionAug 24, 2026No Display/Image; Poor Quality Image; Communication or Transmission Problem
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410599 ↗MalfunctionJul 13, 2026Residue After Decontamination; Communication or Transmission Problem
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES WHITE FOREIGN MATERIAL AND AN E315 (SCOPE COMMUNICATION) ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798159 ↗MalfunctionJul 13, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED SCOPE COMMUNICATION ERROR CODE E227 INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798143 ↗MalfunctionJul 13, 2026Communication or Transmission Problem; Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT WHITE FOREIGN MATERIAL ON THE DISTAL END PLASTIC COVER AND E315 SCOPE ERROR CODE WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797865 ↗MalfunctionJul 13, 2026No Display/Image; Communication or Transmission Problem; Failure to Clean Adequately
THE CUSTOMER REPORTED AN OUT OF BOX FAILURE/SCOPE IS NOT COMMUNICATING PROCESSOR INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25796839 ↗MalfunctionJul 10, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED THAT WHEN PLUGGING IT IN, AN ERROR OCCURRED DURING INSPECTION FOR USE INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25784133 ↗MalfunctionJul 8, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT WHITE RESIDUE INSIDE AIR/WATER CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751060 ↗MalfunctionJul 6, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE OLYMPUS GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER CHANNEL AND CYLINDER WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718150 ↗MalfunctionJun 30, 2026No Display/Image; Communication or Transmission Problem
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. HOWEVER, DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN OBSERVED A SCOPE ERROR CODE E315 WITH A BLACKOUT IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673179 ↗
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- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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